Joe V Selby MD MPH Executive Director ONC HITCP June 5 2013 1 Who We Are An independent research organization authorized by Congress as part of the 2010 Patient Protection and Affordable Care ID: 731707
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Slide1
Building a National Patient-Centered Clinical Research Network
Joe V. Selby, MD, MPH, Executive DirectorONC HITCP June 5, 2013
1Slide2
Who We Are
An independent research organization authorized by Congress as part of the 2010 Patient Protection and Affordable Care Act
We fund
comparative clinical effectiveness research that provides patients and those who care for them the information they need to make better informed health care decisions.
2Slide3
Making The Vision Real
We’ve proposed development of a National Patient-Centered Clinical Research NetworkTwo funding announcements for
up to $68
million.
Clinical Data Research Networks (CDRN).
Patient-Powered Research Networks (PPRN
).
Key Dates: April 23: Funding Announcements Released.June 19: Letters of Intent (LOI) Due.September 27: Applications Due.December: Awards Announced.
3Slide4
Distinct (Complementary) Approaches Emerge
PCORI National Workshop to
Advance Use of Electronic Data
July 2-3, 2012
Clinical Data
Networks
Patient-Powered Research Networks
4Slide5
Participants in the Vision of a National Research Infrastructure
Specialty Societies
Payers
Innovators
and Entrepreneurs
Industry
Meaningful Use
Nationwide Health
Information Network
Federal
Health
Architecture
EHR
Certification
Standards
& Interoperability Framework
ONC
Mini-Sentinel
OMOP
FDA
DRNs
PBRNs
Registries
SPAN
PROSPECT
EDM Forum
AHRQ
SEER Registries
CTSA
Collaboratory
CRN, CVRN
ClinicalTrials.gov
eMERGE
Network
PROMIS
/ NIH
-
Snomed
-CT, LOINC
NIH
VistA
iEHR
(2017)
VA
2011 Report:
Digital Infrastructure for the Learning Health System: The Foundation for Continuous Improvement in Health and Health Care
IOM
5Slide6
What Would Such a Network Look Like?
Characteristics:
A
“network of networks”
Two types of component networks: systems-generated and patient driven networks
Active involvement of health care systems, of clinicians and of patients
A commitment to establishing inter-operability and data sharing across networks and ready collaboration with the larger research
community
Capabilities
:
Rich clinical data from electronic health records and other data sources stored in standardized, interoperable formats.
Capacity to conduct both observational studies and randomized trials embedded in clinical settings
Rigorous practices for data security and confidentialityAppropriate IRB and human subjects oversight
Utility for CER, safety studies, surveillance, etiologic research, and potentially for pre-approval trials6Slide7
What the Ideal Data Network Will Do
What the Ideal Data Network Will Do
7Slide8
National Patient-Centered Clinical
Research Network
8
Patient OrganizationsSlide9
9
National Patient-Centered Clinical
Research Network: Our Vision
Steering Committee
Awardees
PCORI
AHRQ, NIH, FDA, ONC, CMS, VA
Scientific Advisory Board
Special Expert Group
Coordinating Center StaffSlide10
Patient-Powered Research Networks (PPRN)
$12 million to support up to 18 new or existing PPRNs for 18 months
10
COOPERATIVE
AGREEMENT
AWARD
T
arget
size of
0.5%
of U.S population with condition:
(
>
50
patients for rarest diseases;
10,000 for
most
common)
Patient-reported
data collected for at least 80% of cohort
Patients involved
in
governance
Standardized
data suitable for sharing with other infrastructure
members
Patients with a single condition, interested in research participation.
Ability to increase size and diversity of patient membership
Willingness
to build standardized database of patient-reported
data
Willingness to
explore collection of electronic clinical data.
18 MONTHS LATERSlide11
Clinical Data Research Networks (CDRN)
11
$
56 million to support up to
8
new or existing
CDRNs for 18 months
COOPERATIVE AGREEEMENT AWARD
18 MONTHS LATER
At least two health care systems engaged
Willingness and capacity to work toward data standardization with other awardees
Willingness
to participate in collaborative studies with data sharing as part of
a national
r
esearch infrastructure
>
1,000,000 patients enrolled
Data standardized within
network and with
other
awardee networks
Patients
,
system,
and clinicians engaged in
governance & use
Capable
of implementing clinical trialsSlide12
Potential Participants, Partners, Data Sources
12Slide13
Join Us At www.pcori.org